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A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus


N/A
50 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus


Inclusion Criteria:



1. Must be fully consented to the collection of the samples in writing (completed
consent forms).

2. Age Criteria: Women age 50 and older who are post menopausal (defined as 12 months
past last menstrual period).

3. Must have: Diagnosis of an adnexal mass or a suspicion of ovarian cancer, or a
suspected fallopian tube or primary peritoneal cancer.

4. Must have a uterus and cervix.

5. Surgery for the adnexal mass must be anticipated. (Only patients with an adnexal mass
requiring surgery will be eligible).

Exclusion Criteria:

1. Any subject who has a condition that would increase the risk associated with the
standard sampling procedures (Such as a pap smear, or cotton swab in vagina)

2. Prior hysterectomy.

3. Absence of adnexal mass.

4. Primary diagnosis of a cancer other than ovarian, primary peritoneal or fallopian
tube.

5. Patients with grossly visible cervical cancer.

6. Previous/recent treatment for any invasive gynecologic cancer.

7. Recent chemotherapy within the prior 2 years. (recent neoadjuvant chemotherapy for
ovarian cancer would exclude the patient from participation).

8. Cervical conization within the prior 6 months.

9. History of Radiation therapy to the pelvis, vagina or cervix.

10. Obvious advanced stage cancer (Stage III or IV) on presentation, if known prior to
specimen collection.

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Discovery of biomarkers that allow for the early detection of ovarian cancer

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Lewis Pannell, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Alabama

Authority:

United States: Federal Government

Study ID:

USA-MCI GON-1.01

NCT ID:

NCT01787656

Start Date:

January 2013

Completion Date:

August 2015

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

University of South Alabama Mitchell Cancer Institute Mobile, Alabama  36604